Peripheral Mechanical Thrombectomy With Aspiration
Cardiovascular · 21 CFR 870.5150
To mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration.
Recent MDR events
1,318 adverse event reports on file
- ZelanteDVT ClotHunterJul 30, 2026DeathBoston Scientific Corporation2124215-2026-40908
- Artix MT Thrombectomy Device, 4-8mm, 130cmJul 29, 2026MalfunctionInari Medical, Inc.3020347218-2026-00055
- Indigo System Aspiration Catheter 6XJul 27, 2026MalfunctionPenumbra, Inc.3005168196-2026-00234
- Triever24, 24Fr, 90cmJul 27, 2026InjuryInari Medical, Inc.3020347218-2026-00054
- INDIGO SYSTEM LIGHTNING FLASH ASPIRATION TUBINGJul 15, 2026InjuryPenumbra, Inc.3005168196-2026-00231
- INDIGO SYSTEM ASPIRATION CATHETER 12Jul 15, 2026MalfunctionPenumbra, Inc.3005168196-2026-00232
- EXCIPIO LVJul 14, 2026MalfunctionContego Medical, Inc.3011471056-2026-00049
- EXCIPIO SVJul 14, 2026MalfunctionContego Medical, Inc.3011471056-2026-00051
- INDIGO ASPIRATION SYSTEMJul 8, 2026InjuryPenumbra, Inc.3005168196-2026-00229
- TRIEVER20, 20FR, 90CMJul 8, 2026MalfunctionInari Medical, Inc.3020347218-2026-00052
Event type breakdown
Recalls
10 recall events for this product code
- Inari Medical - Oak CanyonOpen, ClassifiedMay 6, 2025
Artix MT Thrombectomy Device, REF: 32-102
Thrombectomy device specifies vessel range of 2.5-6 mm on the pouch, carton, and Instructions for Use rather than the correct vessel range of 3-6 mm, which could incrementally increase the radial force on the artery, which has the potential of vascular complications.
Z-1728-2025 · View FDA record ↗ - Inari Medical - Oak CanyonOpen, ClassifiedAug 21, 2024
ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011
Thrombectomy system catheter instructions for use updated to reduce adverse events due to the following circumstances: 1) Fibrous, firmly adherent, calcified material, or suspected tumor thrombus overloading catheter bag 2) Catheter pulled through internal jugular vein access site or not pulled away from heart; may lead to device entrapment, pulmonary embolism, venous cutdown, abdominal surgery.
Z-2587-2024 · View FDA record ↗ - Mermaid Medical A/SOpen, ClassifiedJun 26, 2024
The D*Clot HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French. The disposable system consists of an outer sheath t
Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.
Z-2213-2024 · View FDA record ↗ - TELEFLEX MEDICAL INCTerminatedFeb 15, 2022
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-12709-CA, PT-12709-C,
The firm received reports indicating PTD tip separation during use.
Z-0623-2022 · View FDA record ↗ - TELEFLEX MEDICAL INCTerminatedFeb 15, 2022
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-65709-HFS
The firm received reports indicating PTD tip separation during use.
Z-0624-2022 · View FDA record ↗ - TELEFLEX MEDICAL INCTerminatedFeb 15, 2022
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C
The firm received reports indicating PTD tip separation during use.
Z-0625-2022 · View FDA record ↗ - TELEFLEX MEDICAL INCTerminatedFeb 15, 2022
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components: PT-65709-C, PT-03009, PT-65709-HS
The firm received reports indicating PTD tip separation during use.
Z-0626-2022 · View FDA record ↗ - TELEFLEX MEDICAL INCTerminatedFeb 15, 2022
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T
The firm received reports indicating PTD tip separation during use.
Z-0627-2022 · View FDA record ↗ - TELEFLEX MEDICAL INCTerminatedFeb 15, 2022
5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-03000, PT-65509-S (PT-65509-S2 alternative)
The firm received reports indicating PTD tip separation during use.
Z-0628-2022 · View FDA record ↗ - TELEFLEX MEDICAL INCTerminatedFeb 15, 2022
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit)
The firm received reports indicating PTD tip separation during use.
Z-0629-2022 · View FDA record ↗
Registered firms
348 firms currently registered for this product code
Penumbra Inc.
Livermore, CA, US
Boston Scientific Corporation
Coventry, RI, US
Angiodynamics, Inc.
Marlborough, MA, US
Isomedix Operations, Inc.
Temecula, CA, US
Centerpiece S. De R.l De C.v (sterilization Site)
Tijuana Baja California, MX
Inari Medical, Inc.
Irvine, CA, US
Synergy Health Ast, Srl
Alajuela, CR
Penumbra, Inc.
Alameda, CA, US
Sterigenics Us Llc
Grand Prairie, TX, US
Sterigenics U.s., Llc
Tustin, CA, US
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center
QUINCY, MA, US
Plexus Manufacturing Sdn. Bhd.
Bayan Lepas Pulau Pinang, MY
Sterigenics Us Llc
Los Angeles, CA, US
510(k) clearances
142 clearances for this product code
- Jupiter EndovascularAug 4, 2026
K261523 · Vertex Thrombectomy System
- Penumbra, Inc.Apr 24, 2026
K260599 · INDIGO® Aspiration System INDIGO Link
- Argon Medical Devices, Inc.Feb 5, 2026
K260028 · CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister
- Penumbra, Inc.Feb 5, 2026
K251949 · INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK
- Verge Medical, Inc.Jan 21, 2026
K253730 · RoVo Mechanical Thrombectomy System
- Avantec Vascular CorporationJan 7, 2026
K251207 · Sangria Thrombectomy System
- Endovascular Engineering, Inc.Dec 18, 2025
K252956 · Helo Thrombectomy System
- Akura MedicalNov 25, 2025
K251070 · Akura Thrombectomy System